12 Aug, 2021

Senior Process Engineer

  • GSK
  • Rosia, Province of Siena, Italy
Process Engineer Biochemicals / Pharmaceuticals

Job Description

Job Purpose

 

Responsible to design and implement highest standard solutions and promote continuous improvement of process equipment and systems within the assigned business segment, by pushing on boundaries of technology.

He/She must have a strong collaboration with manufacturing and QA and full alignment with  Manufacturing Units, Central and Site Engineering.

 

 

Job Description

 

Operations:

  • Design and execute process technology projects in the following business segments: Seed lab, Bulk Production,MSAT, Quality Control, Aseptic Operations and packaging both for Siena and Rosia.

  • Drive execution of process engineering capex, with strong focus on standardization, robustness, harmonization of ways of working, systematic approach. Ensure effective reporting to Process Engineering Manager.

  • Ensure that all process engineering documents are maintained updated.

  • Ensure the execution of projects within the approved scope, time schedule and budget. Ensure effective reporting to Process Engineering Manager.

  • Provide smooth handover of projects for new installations by proper involvement of stakeholders in all critical projects steps.

 

Quality/Regulatory

  • Ensure adherence to cGMP's, GES, standard operating procedures, safety practices.

  • Monitor quality metrics of the assigned process engineering activities in close collaboration with QA. Ensure effective reporting to Process Engineering Manager.

  • Responsible to support  audits for topics related to his/her area of responsibility.

  • Design solution to  fix all process engineering gaps outcomed from Regulatory/Agency Inspection, Audit, Integration/remediation programs and all initiatives to improve compliance level (GMP and HSE).

 

Budget:

  • In the role of Project Manager, is responsible for budgeting, forecasting and cost control of assigned investments.

  • In the role of Process Engineer, is responsible for budgeting, forecasting and cost control of minor capex.

  •  

    Health, Safety Environment

  • Ensure full compliance with all company policies, procedures, safety rules, and regulations.

  • Ensure a cultural approach in terms of safety, behaviors and design.

 

Staff:

 

  • Propose to Lead/Manager personal development program to meet future objectives of the business.

  • Is part of an organization updated to the latest state of art of engineering, values-based, with high performance level and service culture.

  • Management of external resources staffed in the Team.

  • “Preposto per la sicurezza” as per Italian law D.Lgs 81/2008.

 

 

 

Why you?

 

Basic Qualifications:

 

 

We are looking for professionals with these required skills to achieve our goals:

  • Degree in Chemical Engineering, o background Scientifico ingegneristico con esperienza

  • At least 5 years of experience in Pharmaceutical/Biotech Company

  • At least 3 years of experience in Engineering Department

  • Team Working capability

  • Capability to manage multiple projects

  • Understanding of finance related to Capital Projects

  • Fluent  English

  • Ability to read and understand engineering drawings (P&IDs, Electrical Schematics, Control Loop Diagrams, Architectural, and Process Flow Diagrams, etc.)

  • Quantify and analyze system performance, identify performance gaps through continuous improvement tools and make recommendations for improvement to ensure reliability for operations.

 

Specific technical skills (at least strong competence on 3 or more of the following):

  • HVAC (design and troubleshooting on air handling units)

  • Facility design (Material/People flow, clean rooms)

  • Clean Utilities (Generation and distribution of Pure Fluids, principles, troubleshoting and design standards)

  • Plant Utilities (Black Utilities, energy management, electrical standards)

  • Sterility (sterilization principles, Dry heat/depirogenation, eBeam, gamma radiation, isolators)

  • Fill finish isolators

  • Decontamination (Autoclaves, EDS, Incinerators, batch decontamination)

  • Cleaning (cleaning standards and principles, CIP/SIP, COP/SOP, washing machines)

  • Upstream/Downstream Process Operation (cell harvest, centrifugation, purification, chromatography, filtration)

 

Preferred Qualifications: 

 

If you have the following characteristics, it would be a plus: 

  • Able to lead and work within teams and networks across functional and geographical boundaries; leads by example and promotes collaboration; 

  • Demonstrates conceptual, analytical and strategic thinking; 

  • Effective at problem solving and conflict resolution; 

  • Possesses good English language written and verbal communication skills in addition to proven negotiation skills; 

  • Knowledge of local language (Italian); 

  • Ability to deal calmly with complex managerial and technical issues; 

  • Proven influencing skills with the demonstrated ability to act with confidence and credibility in- and outside the Company; 

  • Ability to operate cross-functionally and work well within a matrix environment, balance priorities, and handle multiple tasks through good planning, project administration, and organization skills. 

 

 

Why GSK?

 

Our values and expectations are at the heart of everything we do and form an important part of our culture.

 

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

  • Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk.

  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.

  • Continuously looking for opportunities to learn, build skills and share learning.

  • Sustaining energy and well-being

  • Building strong relationships and collaboration, honest and open conversations.

  • Budgeting and cost-consciousness


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